Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study)

Abstract

Background: Transseptal puncture is a critical step in achieving left atrial (LA) access for a variety of cardiac procedures. Although the mechanical Brockenbrough needle has historically been used for this procedure, a needle employing radiofrequency (RF) energy has more recently been approved for clinical use. We sought to investigate the comparative effectiveness of an RF versus conventional needle for transseptal LA access.

Methods and results: In this prospective, single-blinded, controlled trial, 72 patients were randomized in a 1:1 fashion to an RF versus conventional (BRK-1) transseptal needle. In an intention-to-treat analysis, the primary outcome was time required for transseptal LA access. Secondary outcomes included failure of the assigned needle, visible plastic dilator shavings from needle introduction, and any procedural complication. The median transseptal puncture time was 68% shorter using the RF needle compared with the conventional needle (2.3 minutes [interquartile range {IQR}, 1.7 to 3.8 minutes] versus 7.3 minutes [IQR, 2.7 to 14.1 minutes], P = 0.005). Failure to achieve transseptal LA access with the assigned needle was less common using the RF versus conventional needle (0/36 [0%] versus 10/36 [27.8%], P < 0.001). Plastic shavings were grossly visible after needle advancement through the dilator and sheath in 0 (0%) RF needle cases and 12 (33.3%) conventional needle cases (P < 0.001). There were no differences in procedural complications (1/36 [2.8%] versus 1/36 [2.8%]).

Conclusions: Use of an RF needle resulted in shorter time to transseptal LA access, less failure in achieving transseptal LA access, and fewer visible plastic shavings.

Trial registration: ClinicalTrials.gov NCT01209260.

Keywords: Brockenbrough needle; comparative effectiveness; left atrial access; radiofrequency energy needle; randomized controlled trial; transseptal puncture.

Figures

Figure 1.

Subject flow in the study. *Patients available for analysis of the primary outcome of time of first transseptal puncture. There were no patients excluded from the analysis. RF indicates radiofrequency.

Figure 2.

Total transseptal puncture procedure time by assigned transseptal needle. Box plots show the median (white line) and interquartile range (from top to bottom of the box plot). Each whisker represents the most extreme value within 1.5 times the interquartile range. Outlier values are not shown. Times are inclusive of crossover time.

Figure 3.

Pictured is an example of grossly visible particles that were produced after the introduction of a conventional needle through the dilator and long sheath. The particles are placed on conventional electrocardiography paper as a size reference.